AAPM REPORT NO. 73
MEDICAL LASERS:
QUALITY CONTROL, SAFETY STANDARDS,
AND REGULATIONS
Joint Report
Task Group No. 6
AAPM General Medical Physics Committee
and
American College of Medical Physics
Suresh M. Brahmavar, Ph.D.
Chairman, Medical Laser Task Group
Fred Hetzel, Ph.D.
Chairman, Photodynamic Therapy (PDT) Task Group
October 2001
Published for the
American Association of Physicists in Medicine
and the
American College of Medical Physics
by Medical Physics Publishing
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publication.
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Task Group on Medical Lasers
QC, Safety, Standards and Regulations
Suresh M. Brahmavar, Ph.D.
Chairman, Medical Lasers
Baystate Health System
Springfield, Massachusetts
Fred Hetzel, Ph.D.
Chairman, PDT Task Group
Research & Development
HealthOne
Denver, Colorado
Patrick Clark
Director of Research &
Development
EpiCentre, Inc.
Dallas, Texas
Penny J. Smalley, R.N.
Consultant
1444 W. Farwell
Chicago, Illinois
Cathy Miller, R.T.R.
Assistant R.S.O.
Baystate Health System
Springfield, Massachusetts
iii
Robert Watkins, M.S.
Senior Radiation Physicist
Radiation Control Office
Department of Public Health
Boston, Massachusetts
Leslie Pollard
Medical Laser Safety Officer
Minimal Invasive Surgical
Team Director
St. Joseph’s Hospital
Asheville, North Carolina
Vangie Paschall-Dennis
Advanced Technologist
Promina Gwinnet Health System
Atlanta, Georgia
Terry LaFrance, M.S.
Senior Physicist
Baystate Health System
Springfield, Massachusetts
iv
Contents
Preface .................................................................. vii
Acknowledgments ................................................... viii
I.
Introduction ..........................................................
1
II.
Need For A Laser Safety Program
.............................
3
III.
Current Standards, Federal
And State Regulations .............................................
Medical Laser Standards ............................................
Federal Regulations: FDA/CDRH/OSHA.........................
State Regulations .....................................................
Non-Governmental Agencies: JCAHO...........................
7
7
8
9
9
Laser Bioeffects and Concepts Of Nominal
Hazard Zone (NHZ), Maximum Permissible
Exposure (MPE), Etc. ...............................................
Classification of Lasers...............................................
Common Lasers and Useful Definitions.........................
Basic Biological Effects ..............................................
Laser Tissue Interactions ............................................
Depth of Penetration ................................................
Nominal Hazard Zone (NHZ) .....................................
Maximum Permissible Exposure (MPE) .........................
Exposure Durations ..................................................
11
11
13
14
14
15
15
15
16
V.
Operational Aspects of the Clinical Laser Program
......
Laser Committee .....................................................
Committee Membership ...........................................
Committee Function ................................................
Basic Areas of Controls ..............................................
17
17
17
18
18
VI.
Responsibility and Authority of the Laser
Safety Officer (LSO) ................................................
Consultative Services ................................................
Regulations.............................................................
Authority................................................................
Records .................................................................
Surveys and Inspections ............................................
Accidents ...............................................................
Approval of Laser System Operation ............................
Other Related Responsibilities.....................................
Deputy Laser Safety Officers.......................................
19
19
19
20
20
20
20
21
21
22
IV.
v
Contents
VII.
Quality Control and Radiation Safety ........................
A.
Physical Inspection of Equipment and Accessories .
B.
Laser Safety...................................................
C.
Output Measurements and Quality Control .........
D.
Education and Training ...................................
E.
Summary of Control Measures ..........................
F.
Clinical Laser Systems......................................
G.
Equipment Testing/Clinical Use .........................
VIII.
Laser Safety Procedures for Clinical Use
IX.
Useful Data and Tables ...........................................
Table 1A NHZ Distances for Selected Surgical Lasers
Without Delivery System Constraints .............
Table 1B Laser Criteria Used for NHZ Distance
Calculations..............................................
Table 2 MPE Limits for Selected Surgical/
Medical Lasers...........................................
Table 3 Control Measures for the HCLS.....................
Table 4 Wavelength Effects for Various Lasers .............
Table 5 Laser Safety Training Program ......................
35
X.
Sample Forms ........................................................
Form #1 Laser Quality Assurance...............................
Form #2 Quality Control of Medical Lasers ..................
Form #3 Laser Log and Record .................................
Form #4 Laser Privilege Application Form....................
Form #5 Laser Operator Skills Validation .....................
Form #6AApplication for Registration of a Laser Facility...
Form #6B Inventory of Class IIIB and IV Lasers ...............
41
41
42
43
44
46
47
48
XI.
Operational Procedures ..........................................
Procedure #1
Standards for Approval of Laser Use
by Health Care Professionals .............................
Standards to Credential Physicians
in Laser Therapy.............................................
Standards to Credential Nurses in Laser Therapy...
Credentials and Orientation for Laser Technicians .
Procedure #2 Pre/Post-Operative Safety Checklist..........
Procedure #3 Practical “Rules of Thumb”
for Laser Safety ..............................................
Procedure #4 Non-Beam Hazards ..............................
Procedure #5 Laser Safety Education Program ..............
49
XII.
23
24
25
27
28
28
28
28
.................... 31
35
35
36
37
38
39
49
50
52
53
54
55
58
60
Bibliography ......................................................... 63
vi
Preface
This document is historic for two major reasons. First, it represents the
first jointly authorized publication by both American Association of
Medical Physicists (AAPM) and American College of Medical Physics
(ACMP). This document began as a 1991 ACMP report. In 1997 the
General Medical Physics committee of AAPM invited Dr. Brahmavar,
who authored the original report, to chair a task group to rewrite and
update the document as an AAPM task group report. As it neared
completion, there was a suggestion that perhaps ACMP would be
interested in supporting the revised document. In the spring of 2000 it
was independently approved by both organizations, each of which
endorsed joint publication.
This document is also historic because it addresses unique subject
matter for the two Medical Physics organizations. One of the major
objectives of the current AAPM General Medical Physics committee has
been to bring medical physicists into the two organizations whose
specialty or area of practice is not necessarily radiological physics
(either diagnostic or therapeutic). This document on medical laser
physics represents the first major, visible step in that direction. It also
serves to establish AAPM and ACMP as the national organizations setting
guidelines for this expanding area of Medical Physics.
Fred W. Hetzel, Ph.D., J.D.
Vice President
HealthONE Alliance
1850 High Street
Denver, CO 80218
vii
Acknowledgments
We would like to acknowledge with thanks the help, support, and
special efforts of members of Task Group No. 6 on Medical Lasers,
leadership of AAPM and ACMP, and Mary Kober of Baystate Medical
Center, Springfield, MA, for excellent secretarial assistance given in
preparing this final document for use by other medical physicists
interested in safe use of medical lasers in patient care.
We would also like to acknowledge the extensive use of resource
materials from Rockwell Laser Industries, ANSI Standards and ACMP.
Fred Hetzel, Ph.D.
Chairman, AAPM
PDT Task Group
Suresh M. Brahmavar, Ph.D.
Chairman, AAPM
Medical Laser Task Group
October 2000
viii
I. Introduction
The purpose of this document is to provide hospitals and the Joint
Commission on Accreditation of Hospitals Organization (JCAHO) a
guide prepared by medical physicists recommending tests and procedures for medical lasers to maintain a high level of quality care in a safe
environment. The guidance for safe use of laser systems for diagnosis
and therapy is intended for use by all health care personnel associated
with laser systems’ operation (physicians, nurses, medical physicists),
maintenance (engineers), and service (biomedical technicians). The
suggested controls are based upon evaluation of potential hazards from
laser radiation; unique problems related to operating rooms, outpatient
clinics, and private medical offices; and exposure risks to patients and
personnel. The control procedures are derived from ANSI Standards
Z136.1 and Z136.3. Other resource materials are listed in the
bibliography.
A growing use of medical lasers is in the area of photodynamic therapy
(PDT) where lasers provide a convenient source of intense, narrow
bandwidth light. The safe use of the specialized lasers and fiber optics
for PDT is to be addressed in a companion AAPM Task Group report
and guidance document.
Evaluation of medical laser safety and quality assurance (QA) should be
performed under the direction of a qualified expert, in this case a
medical physicist. Government agencies, independent advisory corporations, and professional societies have published definitions of a
medical physicist and a qualified expert. A medical physicist is an
individual with his/her principal education in physics with a minimum
of a master’s degree plus 4 years of experience in medical physics or a
Ph.D. degree with 3 years of experience in medical physics. A qualified
expert in medical laser safety is an individual who has demonstrated to
the satisfaction of the appropriate supervising or regulatory body that
1
Introduction
he/she possesses sufficient knowledge, training, and experience to
measure laser radiation, to evaluate safety techniques, and to advise
regarding protection for laser radiation.
Not all measurements have to be made by the medical physicist, but all
measurements must be made under the immediate supervision of a
qualified expert. The decision concerning which measurements are
made by a physicist and which can be made by an engineer or a nurse
under the supervision of the qualified expert must be made by the
medical physicist who assumes sole responsibility for interpretation.
2
II. Need For A Laser Safety Program
The term LASER is an acronym for Light Amplification by Stimulated
Emission of Radiation. Lasers are special devices that produce light that
is
monochromatic,
directional,
and
coherent.
These
special
characteristics are utilized in designing laser devices that are used in
industry and in medicine. Industry uses lasers to cut, weld, drill, mark,
and fuse materials. Laser applications include the manufacture of
integrated chips, precise alignment, and communications. Medical uses
of lasers include surgery, dermatology, gynecology, cardiology,
otology, ophthalmology, etc. Recent uses include angioplasty,
photodynamic therapy (PDT), and diagnostic image processing.
In the United States about 500,000 to 700,000 health care workers are
involved in the use of medical lasers. The safety concerns in the use of
medical lasers are related to operators, patients, and laser devices. The
laser hazards are not limited only to the primary beam but also to nonbeam exposure of the environment. The total number of reported accidents for the period 1984 to 1996 is 339, and this number is growing
every year. These data are displayed in diagrams 1 and 2. The major
accident categories are:
•
Unanticipated eye exposure during alignment
•
Misaligned optics and upwardly directed beams
•
Available eye protection not used
•
Equipment malfunction
•
Improper methods of handling high voltage
•
Intentional exposure of unprotected personnel
•
Operators unfamiliar with laser equipment
•
Lack of protection for ancillary hazards
•
Improper storage of equipment following service
•
Failure to follow standard operating procedures (SOPs)
•
Accidental eye/skin exposure during use
3
Need For A Laser Safety Program
Laser hazards involve exposure risks to the eye and skin, as well as fires,
electrical system faults, and emission of fumes/toxic substances.
Diagram 1. Laser Accident Summary: Incidents Reported (1964–1996)
4
Need For A Laser Safety Program
Diagram 2. Laser Accident Summary: Breakdown of 330 Events by Type of Laser
5
Need For A Laser Safety Program
6
III. Current Standards, Federal And State
Regulations
Medical Laser Standards
Medical Laser Standards include:
•
ANSI Z136.1 (2000): Safe Use of Lasers
•
ANSI Z136.3 (1996): Safe Use of Lasers in Health Care Facilities
These standards provide guidance for the safe use of lasers for diagnostic and therapeutic applications in health care facilities. Lasers used
in health care applications are incorporated into an apparatus that
includes a delivery system to direct the output of the laser, a power
supply with control and calibration functions, mechanical housing with
interlocks, and associated fluids and gases required for the operation of
the laser. This document pertains to the safe use of this entire apparatus,
which is referred to as a Health Care Laser System (HCLS). The standard
is intended for use by all persons associated with the installation,
operation, maintenance, and service of HCLSs.
These standards include engineering, procedural, and administrative
controls necessary for the safety of patients and health care professionals. These controls are based upon: evaluation of potential hazards from
laser radiation; unique problems related to operating rooms, outpatient
clinics, mobile laser units, and private medical and dental offices; and
exposure risks to patients and professional staff. Included in these
standards are engineering and administrative controls, personnel
protective equipment, and laser safety training. Suggestions for safe use
of specific types of HCLSs and use of HCLSs in various subspecialties are
included in the appendix of the ANSI standards.
7
Current Standards, Federal And State Regulations
Federal Regulations: FDA/CDRH/OSHA
The Federal Food and Drug Administration (FDA) Center for Devices
and Radiological Health (CDRH) has the responsibility for implementing and enforcing the laws and regulations which apply to radiation-producing electronic products and medical devices. The details are
contained in Code of Federal Regulations (CFR) Title 21, Parts 1040.10
and 1040.11, Medical Devices Act.
Medical devices, including laser systems for medical applications,
require clearance by the FDA in order to be introduced commercially in
the United States. The clearance can follow the review of a premarket
notification under section 510(k) of the Federal Food, Drug and
Cosmetic Act (FFDCA) for a device that is substantially equivalent to a
device that was in commercial distribution in the United States prior to
May 1976 (enactment date of the Medical Device Amendments to the
FFDCA), or to previously cleared devices. Clearance for other devices
requires approval of an application for premarket approval. Clearances
are device specific and for indications claimed in the cleared labeling.
Clinical use of a device for indications that have not been cleared
requires (additional) clearance or use of the device is considered
“investigational.” The FFDCA does not prevent a physician from using a
device in a manner that has not been approved. However, this
investigational or off-label use generally requires approval of an
investigational review board or ethics committee.
Investigational use of a device for which approval for a new indication
is desired by the manufacturer or distributor requires that there be:
•
An investigational protocol limited in scope and duration
•
Approval by an Investigational Review Board (IRB)
8
Current Standards, Federal And State Regulations
•
Approval by the FDA for investigations of devices of significant
risk
•
Informed patient consent
The Occupational Safety and Health Administration (OSHA) regulations
for laser safety are contained in the documents related to Employee Safety
and General Duty Clause. OSHA’s main interest is employee safety for
personnel working in laser use areas. OSHA may arrive for inspection
without notice or upon a complaint by an employee at the institution.
The complaint may not be related to laser use.
State Regulations
Several states, including Arizona, Texas, Illinois, Georgia, Florida,
Massachusetts, and Vermont, currently require registration of medical
lasers. Arizona and Massachusetts have been most successful in formulating regulations for hospital laser use. The regulations cover use of
class IIIB and IV medical lasers and require that the hospital:
•
Designate a Laser Safety Officer (LSO) with designated duties
•
Establish a laser use committee with duties and membership
requirements
•
Report laser-related incidents or safety violations
•
Regularly inspect safety eyewear
•
Perform regular preventive maintenance
•
Conduct routine safety inspection of lasers
•
Follow pre-surgery and post-surgery checkups
Non-Governmental Agencies: JCAHO
To date, JCAHO has not provided a set of written criteria for laser use in
a hospital setting. The JCAHO expectations are that hospital use of lasers
is based on the ANSI standards. JCAHO’s interests lie in procedures,
9
Current Standards, Federal And State Regulations
documentation,
quality
management,
nursing
care,
and
staff
competency. In addition, the inspections include environmental aspects
such as control zones, limited access, and personal protection devices.
The Laser Safety Program must be integrated into the Hospital’s Safety
Programs with a designated LSO, Laser Committee, etc.
10
IV. Laser Bioeffects And Concepts
Of Nominal Hazard Zone (NHZ),
Maximum Permissible Exposure (MPE), Etc.
Classification of Lasers
Lasers and products containing lasers must be classified according to the
amount of radiation accessible during normal usage, not during periods
of service or maintenance. The maximum output energy or power must
be considered when determining the laser classification, even though
normal operation may require less than maximum output. Laser
classification relates to the potential for injury from the beam itself and
not from related dangers such as electrical systems.
A Class I rating for a laser can be obtained by assuring that an operator
cannot have access to hazardous laser energy. This may be accomplished
with very low power lasers that produce less than a hazardous amount
of energy. In the visible spectrum region this amounts to less than 0.4
microwatts of power. A laser may also be considered to be Class I if a
more powerful laser is contained within an enclosure. Operators cannot
be allowed to open this enclosure when the laser beam is present.
During periods of service or maintenance, however, the higher power
laser beam may be accessible.
Class II lasers must be visible. The output power of these lasers must be
low enough so that a person’s natural aversion to bright light will
protect the eye. These lasers must produce less than 1 mW of visible,
continuous wave (CW) light. Provided a person does not force himself
to look into the beam, these lasers are relatively safe. They will not
produce skin burns but are theoretically able to produce eye injuries if
viewed for more than 0.25 seconds. A special classification also exists
called Class IIA. These lasers are not allowed to produce more than Class
11
Laser Bioeffects And Concepts of NHZ, MPE, etc.
I limits for relatively short periods of time. A Class IIA laser must be
designed so that intentional viewing of the beam is not anticipated. A
scanning laser, such as found in supermarkets, designed to read “barcodes” is a typical example of a Class IIA laser.
Class III lasers may be divided into two subgroups. Class IIIA lasers are
allowed to exceed the power limit of Class II by no more than five
times. Thus a continuous wave (CW) visible Class IIIA laser has a
maximum power of 5 mW. Often, these lasers will have an expanded
beam diameter so that no more than 1 mW can enter a fully dilated
pupil, which is 7 millimeters (mm). There are slight variations between
the concepts of IIIA classification as per CDRH or ANSI. For instance,
the ANSI standard allows some invisible lasers to be rated IIIA but the
CDRH standard only allows visible lasers in this class.
Class IIIB lasers may be either visible or invisible, but they cannot
produce more than 500 mW of CW power. Class IIIB lasers produce
enough power to result in an injury before a person could react. Both
the eye and the skin can be injured if exposed to the direct beam
(including mirror reflections) from Class IIIB lasers. Scattered energy
(diffuse reflections) is not considered hazardous in most situations—unless the laser is operating near the upper power limit of Class
IIIB and a diffuse target is viewed at close distances.
Class IV lasers present the greatest potential hazard. Both the eye and
skin can easily be injured. Not only is the direct beam hazardous but
diffuse reflections can also produce injuries. The greatest number of
control measures must be applied to ensure safety of Class IV lasers,
which are capable of producing more than 500 mW of power.
The Class IV lasers produce fire hazards and ocular and skin hazards
when exposure to both the direct beam and the scattered beam occurs.
12
Laser Bioeffects And Concepts of NHZ, MPE, etc.
Common Lasers and Useful Definitions
Common lasers operate in specific areas of the spectrum. There are
several common lasers that produce light in the visible portion of the
spectrum. The argon, HeNe, and ruby are among the most popular
visible light lasers. Other laser types such as Nd:YAG and GaAS diode
lasers operate at a near infrared portion of the spectrum. This region is
invisible to the eye but is close enough to the visible spectrum to act
like visible light when it travels through most standard optical elements.
The CO2 laser generates a wavelength that is very long compared to
visible light. This wavelength is in the far infrared spectral region.
Waves of this length do not transmit through glass components like
lenses or prisms. Optical elements for far infrared energy are made of
exotic materials such as zinc selenide.
The excimer laser is a unique type of laser. It may use several different
gases, which allows it to generate many different wavelengths in the
ultraviolet portion of the spectrum.
The active medium is a collection of atoms, molecules or ions that
absorb energy from an outside source and generate laser light by
stimulated emission. The active medium can consist of a solid, a liquid,
a gas or a semi-conductor material. It is the active material in which the
laser light is produced. This material determines many of the laser
beam’s output characteristics, including its wavelength.
The excitation mechanism is the input energy device. In solid-state
lasers, this mechanism is an intense light source. Gas lasers receive input
energy from a flow of electrical current through the active gas.
13
Laser Bioeffects And Concepts of NHZ, MPE, etc.
The high reflectance mirror and the output coupler compose the
feedback mechanism. These mirrors are specially designed for the laser
wavelength and consist of coatings of vapor deposited on the substrate
to form the reflective surfaces.
Basic Biological Effects
Wavelength Band
Eye
Skin
UV-C (0.200–0.280 microns)
Photokeratitis
Erythema (sunburn)
Skin cancer
UV-B (0.280–0.315 microns)
Accelerated skin aging
Increased pigmentation
UV-A (0.315–0.400 microns)
Photochemical Cataract
Pigment darkening
Photosensitive reactions
Skin burn
Visible (0.400–0.780 microns)
Photochemical and thermal
retinal injury
Photosensitive reactions
Skin burn
IR-A (0.780–1.40 microns)
Cataract retinal burn
Skin burn
IR-B (1.40–3.00 microns)
Corneal burn, aqueous flare,
possibly cataract
Skin burn
IR-C (3.00–1000 microns)
Corneal burn only
Skin burn
Laser Tissue Interactions
Thermal
•
Caused by elevated temperature after absorption of laser energy
•
Nearly all wavelengths and exposure durations
Photochemical
•
Caused by chemical reactions within body tissue after absorption of laser energy
•
Only with wavelength less than 0.550 µm
•
Dominant effect for exposure durations greater than 10 sec
14
Laser Bioeffects And Concepts of NHZ, MPE, etc.
Shockwave (Acoustic)
•
An explosive effect when short pulses are absorbed on the retina
•
Pulse duration less than 10 µsec
Depth of Penetration
Laser Type
Depth (mm)
CO2
0.1
Holmium YAG
1.3
Argon
0.8
Nd:YAG
4.2
Nominal Hazard Zone (NHZ)
The nominal hazard zone (NHZ) is the space within which the irradiance or radiant exposure exceeds the appropriate Maximum
Permissible Exposure (MPE).
If a person is within an area where the laser irradiance exceeds the MPE,
a potential hazard exists and the person must apply appropriate
protective control measures.
According to the ANSI Z136.1 standard, there may be four different
scenarios in which exposure may occur. Each situation has a formula to
use for determining the NHZ.
Maximum Permissible Exposure (MPE)
MPE is the acronym for Maximum Permissible Exposure. As defined by
ANSI Z136.1, “Standard for the Safe Use of Lasers,” the MPE is:
The level of laser radiation to which a person may be exposed without hazardous
effect or adverse biological changes in the eye or skin.
15
Laser Bioeffects And Concepts of NHZ, MPE, etc.
Actual MPE values vary according to the laser wavelength and the
exposure duration. Different values can be determined for intrabeam
laser exposure, extended source laser exposure or exposure to the skin.
Exposure Durations
30,000 sec
Occupational 8-hour work day
600 sec
Visible wavelengths used for alignment purposes
0.25 sec
Normal eye aversion response to bright visible
light
10 sec
For normal maximum exposure time, infrared
wavelengths due to natural body movement
24 hr
Accumulate “on” time for ultraviolet wavelengths
over 24 hours
The above exposure times are required by ANSI Z136.1, “Standard for
the Safe Use of Lasers” when determining the MPE for a laser hazard
evaluation. In some situations the exposure duration is determined by
the laser parameters, but in other situations the “informed judgment”
of the laser safety officer may be relied on to determine potential
exposure durations.
16
V. Operational Aspects
Of The Clinical Laser Program
The decision to use medical lasers in a health care facility should be
followed by a commitment by the management to establish a viable
Laser Safety Program for the institution. The Laser Safety Program
should address the needs of the Clinical Laser Program (CLP) for the
specific use of medical lasers. The elements of a successful laser safety
program are establishment of a laser committee, committee membership, committee functions, and basic areas of controls for safe use of
medical lasers.
Laser Committee
•
Function
•
Promote “safe” laser use
•
Administer policies and procedures
•
Oversee credentialing process
•
Assist in equipment evaluation
•
Monitor quality assurance activities
Committee Membership
•
Physician from each laser specialty
•
Administration
•
Laser Nurses, each area
•
Anesthesiology
•
Biomedical Engineering
•
Laser Safety Officer (LSO)/Medical Physicist
17
Operational Aspects Of The Clinical Laser Program
Committee Function
•
Policies and Procedures
•
Credentialing
•
Coordinating on Laser Activity
•
Appoint a Laser Safety Officer (LSO)
Basic Areas of Controls
•
Administrative Controls
•
Procedural Controls
•
Maintenance and Service
•
Establish Laser Controlled Areas
18
VI. Responsibility And Authority
Of The Laser Safety Officer (LSO)
The Laser Safety Officer (LSO), under the supervision of a Medical
Physicist, will be responsible for the knowledgeable evaluation and
control of laser hazards, and has the authority to monitor the use of
laser equipment and to enforce regulations for the control of laser hazards. The Medical Physicist may also be designated the LSO. In the
absence of a designated LSO, JCAHO considers the institutional
Radiation Safety Officer (RSO) responsible for LSO functions.
Consultative Services
The LSO will provide consultative services for evaluation of laser hazards and controls for personnel training programs. Such evaluation will
include electrical and other non-radiation hazards of lasers, but does not
encompass performing such tasks, which are the appropriate domain of
the laser service engineer. The LSO will provide consultative services for
evaluation of laser environment and plume effects and in matters related
to epidemiology and risk management.
Regulations
The LSO may establish and maintain adequate regulations for the
control of laser hazards. Such regulations will meet compliance
requirements of FDA/CDRH, ANSI Standards Z136.1 and Z136.3, and
state regulations (e.g., Massachusetts Department of Public Health
regulations 105 CMR 121).
The LSO is also responsible for compliance with federal, state, and other
regulations regarding laser installation, the laser safety program, and
registration with appropriate regulatory agencies.
19
Responsibility and Authority Of The LSO
Authority
The LSO will have the authority to suspend, restrict or terminate the
operation of a laser or laser system if he/she deems that laser hazard
controls are inadequate.
Records
The LSO will ensure that the necessary records required by applicable
government regulations are maintained. The LSO will ensure that
applicable medical surveillance examinations have been scheduled and
performed, that appropriate training has been provided, and that
appropriate documentation has been completed and submitted to the
appropriate administrative office.
Surveys and Inspections
The LSO will survey by inspection, as considered necessary, all areas
where laser equipment is used. The LSO will also accompany regulatory
agency laser equipment inspectors, such as those representing OSHA,
FDA/CDRH, state agencies, etc., and document any discrepancies noted.
The LSO will ensure that corrective action is taken where required.
Accidents
On notification of a known or suspected accident resulting from
operation of a laser, the LSO will investigate the accident and initiate
appropriate action. This may include the preparation of reports to
applicable agencies. It is recommended that AAPM, ACMP, FDA or Laser
Institute of America (LIA) establish a device/incident reporting system
for medical lasers. This system could also serve as a clearinghouse for
manufacturer/user information.
20
Responsibility and Authority Of The LSO
Approval of Laser System Operation
Approval of a laser or laser system for operation will be given only if
the LSO is satisfied that laser hazard control measures are adequate.
These include special operating procedures for maintenance and service
operations within enclosed systems and operational procedures for Class
IIIB and IV systems. The procedures will include adequate consideration
to assure safety from electrical, mechanical, procedural, and laser
hazards.
Other Related Responsibilities
•
Evaluate possible hazards and institute appropriate control measures
and training
•
Ensure evaluation of the Nominal Hazard Zone (NHZ) for each laser
system
•
Evaluate a pre-op and post-op safety checklist for each laser
procedure
•
Establish guidelines for safety eyewear and other safety equipment
and assure proper selection and usage for each laser system
•
Ensure all lasers are used according to hospital standards
•
Monitor quality control procedures and conduct radiation safety
audits
•
Establish Maximum Permissible Exposure (MPE) for personnel
compliance standards for health care personnel
•
Establish training guidelines, personnel categories, and credentials
for operators and users of medical lasers. Refer to Procedure #1
21
Responsibility and Authority Of The LSO
Deputy Laser Safety Officers
If necessary, Deputy Laser Safety Officers will be appointed by management in consultation with the LSO. The Deputy Laser Safety Officer
(e.g., Laser Nurse) will perform the functions of the LSO when the
latter is not available.
22
VII. Quality Control And Radiation Safety
The Quality Control (QC) and Radiation Safety (RS) tests as recommended by all the standards are presented in the format of the ACMP
document published in 1991, “Radiation Control and QA of Medical
Laser Systems.” The parameters include basic QC and service tests,
reasons for conducting such tests, references to the ANSI standard sections, and reasonable frequency of such tests. These parameters are
included to help resolve some of the concerns involved in clinical use of
medical laser systems. The appropriate tables and sample copies of
forms for use are referenced and included in later sections of this
report.
The measurements and evaluations described in this protocol are
intended for annual or otherwise routine surveys. They are considered
the minimum acceptable for a properly managed medical laser service.
Similarly, the method of testing a particular parameter is not specified.
For some measurements and tests other equally effective methods are
available. The choice is left to the professional judgment of the qualified
expert.
23
Quality Control And Radiation Safety
PARAMETER
REASON
CRITERIA/FREQUENCY
A. PHYSICAL INSPECTION OF EQUIPMENT AND ACCESSORIES
1. ELECTRICAL AND COOLING
2.
3.
a.
Mechanical and electrical integrity
of plugs, wires and outlet.
b.
Check water hoses for leaks and
wear.
Visual inspection of equipment to
determine mechanical malfunction
or electrical hazard which may lead
to improper operation of equipment
or hazard to patients or personnel.
Before each use.
Good safety practice
Each day of use
CHEMICAL AND SMOKE
a.
Check gas tanks, valves and fittings
for leaks.
b.
Insure tanks are not creating an
obstacle.
"
"
c.
Do not expose tanks to Temp. above
125 degrees F.
"
"
d.
Cylinder valves must be closed
when not in use.
"
"
e.
Smoke evacuation system must be
employed when applicable.
"
"
f.
Gas tanks must be properly secured.
"
"
WARNING SIGNS
Proper labeling by Laser-Type
a.
Post on Doors.
b.
Post on Lasers.
Warn personnel and protect staff.
"
Each case.
"
4. EYEWEAR
a.
Labeled OD and wavelength.
b.
Periodic cleaning and inspection.
c. Check for cracking, discoloration,
leaks.
d. Ensure proper eyewear used with
type of Laser-In-Use.
Visual inspection to insure integrity
of eyewear, to confirm adequate
number are available, and to
confirm that appropriate wavelength
filters are used.
ANSI Z136.1, 4.2.2-4.
As determined by the
institution or LSO.
Visual inspection to insure integrity
of eyewear, to confirm adequate
number are available, and to
confirm that appropriate wavelength
filters are used.
ANSI Z136.1, 4.6.
As determined by the
institution.
24
Quality Control And Radiation Safety
PARAMETER
REASON
CRITERIA/FREQUENCY
a. Check for light leaks.
To prevent unwanted exposure to
personnel and patient.
Before each use.
b. Check that filter is in optical
chain/microscope.
When necessary to protect surgeon.
Each use.
Electrical Safety.
ANSI Z136.3, 7.2.
5. FILTERS AND OPTICS
B. LASER SAFETY
1. ELECTRICAL HAZARDS
a.
All HCLS shall be installed &
operated in conformity with the
National Electrical Code (NFPA70),
OSHA, JCAHO, and Related State
& Local laws and regulations.
b.
Interlocks and removable protective
housing.
c.
Audits, i.e., damaged cords &
cables, not properly grounded
equipment, not returned to original
operating condition, proper training,
etc.
"
ANSI Z136.1, 4.3.2.
To avoid electrical shock.
ANSI Z136.3, 7.2.
2. COMBUSTION HAZARDS
a.
Saturate gauze, drapes, tape, etc.,
with normal saline.
Dry materials are highly flammable
when irradiated by laser beam.
Each use, depending on
laser in use.
b.
Use with non-combustible materials.
Insure ventilation techniques,
shielding with wet substrates.
To avoid potential for release of
chemical vapors and to avoid burns.
ANSI Z136.3, 7.5.1.
c.
Use caution with flammable
anesthetic gases. Low combustion
gas (Helox) mixtures.
To avoid explosion.
ANSI Z136.3, 7.5.1.
d.
Rooms should be equipped with a
portable fire extinguisher in keeping
with NFPA or state and local
building codes.
For Emergency Use.
ANSI Z136.3, 7.5.
e.
Use non-flammable endotracheal
tubes, FDA approved tubes and tube
wrapping. Protect inflated cuff with
wet cotton towelettes.
To prevent laser penetration and/or
ignition of tube.
ANSI Z136.3, 7.5.1.
f.
Test all “Laser Safe” products in
use.
To prevent fires, explosion and
ignition of products used.
Each new batch.
To ensure that personnel exposures
are within safety limits.
ANSI Z136.3, See Tables
1A, 1B.
3. NOMINAL HAZARD ZONES
a.
Establish and post limits of NHZ.
25
Quality Control And Radiation Safety
PARAMETER
b.
4.
Consideration given to room design,
proper ventilation, exhaust,
windows & viewing areas.
REASON
CRITERIA/FREQUENCY
Highly reflective areas limited.
ANSI Z136.3, 7.10.
To avoid laser damage to personnel.
ANSI Z136.1, Tables 5, 6,
7; ANSI Z136.1.8; ANSI
Z136.3, See Table A2.
MAXIMUM PERMISSIBLE
EXPOSURE
a. Establish and post MPE times.
5. PERSONNEL SAFETY
a.
Eye protection mandatory for Class
IIIB and IV lasers, Collateral &
Plasma Radiation.
To filter out harmful, often invisible
laser energy.
ANSI Z136.1, 4.6 / Each
case.
b.
Laser warning signs should be
posted outside room where laser is
being used.
Prevents personnel from entering
room without wearing protective
glasses.
ANSI Z136.1, 4.7 / Each
case.
c.
Ventilation of airborne contaminants
and plume control.
Protects personnel from inhaling
noxious fumes.
ANSI Z136.3, 7.4 / When
necessary.
d.
Cover windows with non-reflective
material.
To avoid inadvertent exposure to
direct or scattered laser radiation.
When necessary.
e.
Permit only experienced personnel
to operate laser; use key switch for
security.
Insures use of laser by experienced
and approved staff.
ANSI Z136.3, 5
Institutional-Policy and
Procedures.
f.
Eliminate unnecessary specular
(mirror-like) surfaces.
Prevents accidental exposure to
laser radiation.
ANSI Z136.3, 5
Institutional-Policy and
Procedures.
g.
Medical surveillance: Baseline eye
examinations; Class IIIB and IV.
Protects institution.
ANSI Z136.3, 6 /
Determined by LSO and
Institutional Health Service.
h.
Further information of value to
examination by attending physician.
For follow up.
ANSI Z136.1 / (2000)
Appendix E.
6. PATIENT SAFETY
a.
Eye protection for Class IIIB and IV
lasers mandatory. Method approved
by LSO.
Prevents damaging exposure to
patient’s eyes.
ANSI Z136.3, 4.4.4.
b.
Use moistened eye pads over taped
eyes.
Reduces accidental skin burns and
exposure.
Depending on laser in use.
Every patient when
applicable.
c.
Surgical field covered with wet
towels.
Reduces accidental skin burns and
ignition of drapes.
Policy/Procedures.
d.
Reflective objects must have a dull,
non-reflective finish or be draped.
Avoid reflecting potentially harmful
laser beam.
Policy/Procedures.
26
Quality Control And Radiation Safety
PARAMETER
REASON
CRITERIA/FREQUENCY
e.
Smoke evacuation system & wall
suction are the two major types of
local exhaust ventilation.
To prevent patient and medical staff
from inhaling noxious fumes.
Reduces LGAC levels.
ANSI Z136.3, 7.3.2 &
7.3.2.1 / Depending on laser
in use.
f.
Know emergency action for fire.
To prevent panic, insure quick and
knowledgeable response.
Every patient when
applicable.
g.
Be familiar with management of
endotracheal fire.
To prevent panic, insure quick and
knowledgeable response.
Part of Disaster Plan.
C. OUTPUT MEASUREMENTS AND QUALITY CONTROL
1. MEASUREMENTS
a.
Output (power/energy
measurements).
To insure proper power/energy is
delivered.
Accuracy ±20% / Monthly.
b.
Accuracy of exposure.
To insure timing accuracy.
See Sample Form #1 or
Form #2.
2. CLEANING
a.
Mirror.
To insure proper output.
As necessary.
b.
Surface ends and types of Fiber
Optics.
To allow proper delivery.
As necessary.
c.
Smoke Evacuation Filter.
For safety of personnel and patient.
As necessary.
Visual inspections to determine
mechanical malfunctions which
may lead to improper operation of
equipment or hazard to patients or
personnel.
Monthly – See Sample
Form #1 or Form #2.
3. INSPECTIONS
a.
Eyewear.
b.
Electrical.
Daily.
c.
Signs.
Daily.
d.
Laser Use Logs.
"
Daily.
e.
Safety Interlocks.
"
Daily.
4. ALIGNMENT
a.
Mirror.
To allow proper power delivery.
Each Use.
b.
Beam.
To allow proper power delivery.
Each Use.
c.
Coincidence of Aiming.
To insure accurate radiation
delivery of laser.
Each Use.
27
Quality Control And Radiation Safety
PARAMETER
REASON
CRITERIA/FREQUENCY
To insure effective and safe delivery
of appropriate laser therapy.
To insure effective and safe delivery
of appropriate laser therapy.
Daily/laser dependent.
5. LASER OPERATOR CHECKLIST
a.
Pre-op/Post-op.
b.
SOPs.
c.
Daily start-up.
"
d.
Laser user log.
"
See Sample Procedure #2.
"
See Sample Form #3.
D. EDUCATION AND TRAINING
1. DEVELOP A TRAINING PROGRAM
a.
Education.
b.
Didactic Training.
c.
Practical Experience.
d.
Criteria to Credential Laser User.
ANSI Z136.3, 5 / (1996).
Appendix D, Tables D1, D2.
To insure that staff is properly
trained in laser use and safety, e.g.,
Health Care Professionals, Laser
Technicians, Service Engineers, etc.
As determined by institution
using laser. See Sample
Procedure #1.
See sample Form #4.
2. LSO RESPONSIBILITIES
To insure compliance and radiation
safety.
ANSI Z136.3, 1.3 / (1996).
E. SUMMARY OF CONTROL
MEASURES
To insure Administrative,
Engineering Preventative
Maintenance, Clinical, Radiation
Safety and Operation Controls.
ANSI Z136.3 / (1996) and
ANSI Z136.1 / (2000).
For major use in treatment of
lesions in Gynecology,
Neurosurgery, General Surgery,
Dermatology, Urology,
Opthalmology, Gastroenterology,
and Otolaryngology.
ANSI Z136.3 / (1996)
Appendix B gives a detailed
survey of clinical operations.
F. CLINICAL LASER SYSTEMS
CO2, Argon, Nd-YAG, Dye Laser
Eximer, solid state, etc. Continuous or
pulsed exposure to be grouped by laser
type.
G. EQUIPMENT TESTING/ CLINICAL USE
1.
Laser must be in normal working order.
Patient and Operator Safety.
Before each use.
2.
The focusing lens of colposcope (in
GYN applications) and lens of the laser
attachment must have the same focal
length.
To avoid uncontrollable damage to
target tissue causing blistering and
extension of heat coagulation zone.
Before each use.
3.
Ensure proper coupling of an articulated
arm to the micromanipulator of the
colposcope.
Misalignment in coupling may
misdirect an active laser beam
towards anesthetists, nursing staff or
patient.
Before each use.
28
Quality Control And Radiation Safety
PARAMETER
REASON
CRITERIA/FREQUENCY
4.
All foot pedal controls should be
covered. Operator should remove foot
from shutter control pedal and put laser
in standby when not actually using laser.
To prevent accidental laser
exposure.
Policy/Procedures.
5.
When using a laser hand-piece in a
sterile field, a sterile stockinette should
be taped at least 4 cm above aperture of
the laser hand-piece.
To prevent slippage into the beam
and ignition of the sterile covering.
Policy/Procedures.
6.
Ensure anodized or matte-finish surgical
instruments are used when laser is
present.
To reduce potential for damage to
the eye by scattered energy from
visible and infrared lasers.
Check before each use.
7.
Only quartz or diffusely reflective metal
should be placed behind adhesions
which are to be severed by lasers. Glass
rods should not be used.
The thermal stress may cause
breakage of glass rods and
fragments may be lost in the cavity.
Policy/Procedures.
8.
Ensure use of eye protection of adequate
optical density and that it is designed for
wavelength of the laser used.
To prevent damage to the cornea,
lens, or retina (depending on
wavelength).
Before each use.
9.
Effective Fume and Plume control either
by suction or special devices is
imperative.
To eliminate offensive odors and
cellular debris, vapors, etc., thus
providing greater visibility for
increased precision. Also to prevent
dispersion of neoplastic debris.
Before each use.
10. Carbon must be removed from the
treated surfaces by suction or irrigation.
To prevent initiation of a foreign
body giant-cell reaction due to
excess carbon deposits and fire.
Policy/Procedures.
11. Ensure that lasers are used at highest
controllable power settings and are
highly maneuverable.
To avoid lateral thermal damage to
the surrounding tissues. Carbonized
impact sites must not be lasered
repeatedly. Impact sites must be
wiped clean of carbon.
Policy/Procedures.
12. Masks should be worn by all personnel.
Proper plume control devices should be
used.
To avoid inhalation of biologically
active material.
Policy/Procedures.
13. Do not prepare operating field with
volatile agents or drape with dry towels
or paper.
To prevent a flash fire when laser
beam strikes a volatile area of the
operating field.
Policy/Procedures.
14. Avoid high-frequency ventilation system
when operating through microscope.
Motion of the surgical field makes
target focusing difficult.
ANSI Z136.3 / (1996)
Policy/Procedures.
15. Non-explosive anesthetics and localized
ventilation techniques are mandatory for
digestive and endotracheal operations.
Methane gas in the digestive tract or
oxygen concentration in the aerodigestive tract poses danger of an
explosion.
ANSI Z136.3 / (1996)
Policy/Procedures.
29
Quality Control And Radiation Safety
PARAMETER
REASON
CRITERIA/FREQUENCY
16. Thorough understanding of biological
tissue and interaction of different laser
wavelengths of laser system is essential.
Thermal mechanism (vaporization,
photocoagulation), mechanical and
nonthermal effects and photochemical reactions are possible.
ANSI Z136.3 / (1996)
See Table 4.
17. Alignment of CO2 and Nd:YAG laser
beam with coaxial HeNe aiming laser
much be checked in each case.
Focusing and coaxial orientation
can be checked with beam aimed at
wet tongue depressor.
Policy/Procedures.
18. Do not use a laser with the articulated
arm unattached or disconnected from a
micro-manipulator or other attachment.
Laser beam can be directed
accidentally toward personnel or
patient.
See Procedure #3.
19. Eye protection for operating personnel
must be appropriate for each laser
wavelength and beam intensity.
Examples:
- For CO2 laser, clear plastic goggles
or glasses with side shields.
To absorb reflected energy and
protect the cornea or retina of the
eyes.
Policy/Procedures.
20. Eye protection for the patient is
necessary; metal and acrylic eye shields
for laser treatment over eyelid area;
moistened eye pads placed over taped
eyes, overlaid with a wet sponge for use
of a laser near the eyes; in addition, for
Nd-YAG laser therapy, aluminum foil
layered over the eyes.
To protect the patient’s eyes from
damage.
Policy/Procedures.
21. Endotracheal tubes of red rubber with
aluminum wrap for CO2 laser in the
aerodigestive tract, PVC endotracheal
tube for Nd-YAG laser.
To avoid burning of the patient’s
endotracheal passage.
Policy/Procedures.
22. Windows should be covered when using
a Nd-YAG laser.
To protect personnel from laser
light reflected from the windows.
Policy/Procedures.
-
For Argon laser, amber tinted
goggles will permit viewing of
Argon wavelengths.
-
For Nd-YAG lasers, goggles
specifically designed for 1.06 µm
wavelengths are necessary.
-
With rigid and flexible
bronchoscopes, wavelength specific
filters protect the surgeon’s eyes.
-
Do not look directly at the laser
beam of a HeNe laser.
30
VIII. Laser Safety Procedures (LSP) For Clinical Use
The Laser Safety Procedures (LSP) are given for practical and easy use in
routine operations. The LSP #1 through #8 are grouped to include all
aspects of use of medical lasers in health care facilities. The LSPs serve as
a quick reference guide to develop and implement a Laser Safety
Program that will comply with recommendations of existing standards.
LSP #1 - All persons should be aware of area of use and controlled access to these areas must be maintained.
•
The nominal hazard zone (NHZ) should be identified to prevent
unintentional exposure to laser beam
•
The NHZ should be occupied by authorized personnel
•
Personnel in NHZ should be aware of all laser safety precautions
•
Regulation laser signs should be placed in all entrances to warn
on-lookers of potential hazard
•
Doors in NHZ should remain closed and windows covered
LSP #2 - Everyone in NHZ should wear appropriate eyewear
approved by LSO.
•
The protective eyewear should be appropriate to wavelength
used and labeled with appropriate Optical Density
•
Patient’s eyes and eyelids should be protected by wet eyepads,
laser protective eyewear, eyeshields, etc.
LSP #3 - Exposure to smoke plume generated during Laser
Surgery should be reduced by implementing a variety of
engineering controls.
•
High filtration surgical masks
•
Wall suction units with in-line filters
•
Smoke evacuator units
31
Laser Safety Procedures (LSP) For Clinical Use
•
Smoke plume has mutogenic and carcinogenic potential. There
is also an unidentified potential for bacterial and viral
contamination
LSP #4 - All persons in laser treatment area should be protected from laser beam exposures to their skin and other
non-targeted tissues.
•
Exposed tissues around the operative site should be protected
with saline-saturated fire/flame retardant materials
•
Anodized, dull, non-reflective or matte-finished instruments
should be near the laser site
•
When a fiber is used to deliver laser energy through an endoscope, the end fiber must extend beyond the end of the endoscope. Most flexible fiber-optic endoscope sheaths are
flammable and are easily damaged by heat
LSP #5 - All persons in laser treatment area should be protected from flammability hazards associated with laser
usage.
•
Fire is one of the significant hazards of laser use
•
The intense heat of laser beams can ignite combustible/flammable solids, liquids, and gases
•
Free flow of high oxygen can lead to rapid spread of flames
•
Fire extinguishers and water/saline should be immediately
available
•
Endotracheal tubes used in patient’s airway should have protection to minimize fire hazard. Standard endotracheal tubes are
combustible
LSP #6 - All personnel should be protected from electrical
hazards associated with laser use.
•
Visual inspection of laser equipment should be done after setup
for use
32
Laser Safety Procedures (LSP) For Clinical Use
•
Laser service and preventive maintenance should be documented. LSO should review records and approve equipment use
after service
LSP #7 - Personnel working in NHZ should demonstrate
competency commensurate with their responsibilities.
•
Surgeons, laser operator (nurse), LSO or designee, biomedical
technician, and other health care personnel
•
Education and training programs should be specific to laser systems and procedure used in the facility
•
Personnel should be required to demonstrate periodically and to
complete competency checklist for new laser systems and
accessories before use
LSP #8 - Policies and procedures for laser safety should be
developed with regard to individual practice settings,
acceptable standards, and federal and state regulations.
•
Policies and procedures should be reviewed periodically, revised
as necessary, and readily available to personnel
•
Establish guidelines for Quality Assessment
•
Laser Safety Committee and structure
•
Administrative and Procedural Controls
•
Education and Training Programs
•
Medical Surveillance and Safety Audits
•
Laser Service and Maintenance
33
IX. Useful Data And Tables
Table 1A
NHZ Distances for Selected Surgical Lasers
Without Delivery System Constraints
MPE
Exposure Time
Criteria(s)
Diffuse*
NHZ (m)
Laser with Lens**
CW Visible***
400–700 nm
0.25
None
3.6
500
CW Nd:YAG
1064 nm
10
0.79
6.37
500
CW CO2
10,600 nm
10
0.18
2.38
178
1–20 ⋅ 10-9
None
0.45
226
Laser Type
Q-SW
Nd:YAG
1064 nm
Laser without
Lens
* It is assumed that worst-case reflection (ρ = 1) and worst-case viewing angle (cos θ = 1) prevail, viewing distance
>20 cm.
** Distance from focus.
*** HeNe, Argon, dye, etc.
Table1B
Laser Criteria Used for NHZ Distance Calculations
Laser Parameter
Wavelength (nm)
CW
Visible
400–700
CW
Nd:YAG
1064
CW
CO2
10,600
Q-SW*
Nd:YAG
1064
Beam power (W)
5
100
100
--
Beam energy (mJ)
--
--
--
2
Beam divergence (mrad)
1
2
2
1
Beam size at aperture (mm)
2
2
20
25
Beam size at lens (mm)
3
6.3
30
25
Lens focal length (mm)
200
25.4
--
5.1 × 10
1.0 × 10
--
MPE (µW / cm2) @ 0.25 s
2.5 × 103
--
--
--
MPE (µJ / cm2) @ 1–20 ns
--
--
--
5
2
MPE (µW / cm ) @ 10 s
200
3
* Typical for ophthalmological use.
35
50
5
Useful Data And Tables
Table 2
MPE Limits for Selected Surgical/Medical Lasers
Laser Type
Exposure Time (seconds)
10**
600***
MPE (mW · cm −2)
---
Wavelength
(nm)
0.25*
ArF
193
--
XeCl
308
--
--
--
0.0013
XeF
351
--
--
--
0.0333
Argon
514
2.5
--
0.0167
0.001
Krypton
530
568
647
2.5
2.5
2.5
--
0.0167
0.031
0.363
0.001
0.00186
0.0285
Dye Laser (a)
630
2.5
--
0.263
0.0158
He-Ne
633
2.5
--
0.293
0.0176
GaAs (CW)
840
--
1.9
0.69
0.610
Q-switched (b)
1064
--
0.017
0.0061
0.0023
Nd:YAG (CW)
1064
--
5.1
1.82
1.6
Nd:YAG (CW)
1330
--
40
14.5
13
10,600
--
100
100
100
30,000****
0.0001
(diode)
Nd:YAG
CO2
(a)
Argon laser pumped Rhodamine 6-G dye laser used in PDT therapy.
(b)
Repetitively pulsed @ 11 Hz, 12 ns pulses.
* Aversion response time.
** Unintentional viewing at wavelengths greater than 700 nm, with no visible component.
*** Intentional viewing of diffuse reflections from small sources (less than αmin).
**** Cumulative exposure, 8-hour working day.
36
Useful Data And Tables
Table 3
Control Measures for the HCLS
(American National Standard Z136.3 – 1996)
1
3b
4
Research (4.1.1)
X
X
Administrative Controls (4.2)
X
X
Laser Use Committee (5.1)
X
X
Maintenance and Service (4.2.1)
X
X
Standard Operating Procedures (4.2.2)
X
X
Authorized Personnel (4.2.3)
X
X
Equipment Controls (4.3)
X
X
Guarded Switch (4.3.1)
X
X
Beam Delivery Disconnect Safety Features (4.3.2)
X
X
HCLS Warning Labels (4.3.3)
2a
2
3a
X
X
X
X
X
Service and Repair of HCLS (4.3.4)
X
X
X
X
X
X
Modification of HCLS (4.3.5)
X
X
X
X
X
X
X
X
Quality Control and Safety Audits (4.3.6)
•
HCLS Output Calibration (4.5.1.1)
Area Posting Sign (4.4.2.1)
Environment in which Laser is Used (4.4.1)
**
**
•
•
X
X
•
•
X
X
**
**
**
**
X
X
Laser Treatment Controlled Area (4.4.2)
Optical Fiber Surgical Probes (4.4.3)
**
**
Alignment Procedures (4.5.1)
**
**
**
**
X
X
X
X
X-NHZ
X-NHZ
X
X
X-NHZ
X-NHZ
Patient Eye Protection (4.4.4)
Service Personnel (4.5.2)
X
X
X
X
Protective Eyewear (4.6.2)
Protective Clothing (4.6.4)
**
Warning Signs / Labels (4.7)
Explosion and Fire Hazards (7.5)
Legend:
X
X-NHZ
•
**
**
**
**
**
**
•/X
•/X
•/X
•/X
•/X
X
- Shall
- Shall within the NHZ
- Should
- LSO shall establish alternate controls
37
Useful Data And Tables
Table 4
Wavelength Effects for Various Lasers
Laser Type
Wavelength
(nm)
Mechanism
Skin
Tissue Affected
Cornea
Lens
Retina
ArF (Pulsed)
193
Photodissociative
X
X
XeCl (Pulsed)
308
Thermal/Photodisruptive
X
X
(a)
(a)
He-Cd (CW)
325
Thermal/Photodisruptive
X
X
X
X
XeF (Pulsed)
351
Thermal/Photodisruptive
X
X
X
Argon (CW)
488 – 514
Thermal/Photodisruptive
X
(b)
(KTP) (Pulsed)
532
Thermal/Photodisruptive
X
X
He-Ne (CW)
633
Thermal
X
780 – 950
Thermal
X
Doubled Nd:YAG
GaAs (Pulsed) (diode)
Nd:YAG (Pulsed)
Thermal/Photoacoustic
X
1064, 1330
Thermal
X
X
Erbium:YAG (Pulsed)
1540
Thermal
X
X
Holmium:YAG (Pulsed)
2100
Thermal
X
X
2730
Thermal
X
X
2940
Thermal
X
X
10,600
Thermal
X
X
Nd:YAG (CW)
1064
X
Hydrogen Fluoride
(Pulsed)
Erbium:YAG (Pulsed)
CO2 (CW)
(a) Simultaneous cornea/lens/retinal effects observed in some biological studies.
(b) Photochemical effects dominate for long term exposures of retina (exposure times >10 sec.).
38
X
X
Useful Data And Tables
Table 5
Laser Safety Training Program
MD
RN
Tech
Service
LSO
1)
Laser Physics/Biological Effects
X
X
X
X
X
2)
System Components/Delivery Devices/
X
X
X
X
X
Instrumentation
3)
Federal, State, Local Regulations
X
X
X
X
X
4)
ANSI Z136.3 Standards
X
X
X
X
X
5)
Institutional Policy/Procedures
X
X
X
X
X
6)
Hazard Classification
X
X
7)
Access to Laser Key
8)
Medical Surveillance
9)
X
X
X
X
X
Documentation/Incident Reporting
X
X
10)
Anesthesia Hazards/Controls
X
X
X
11)
Personal Protective Equipment
X
X
X
12)
Patient Protection
X
X
X
13)
Operational Skills Workshops
X
X
X
14)
Procedure for Safety Audits
X
X
X
X
X
X
X
X
X
39
X. Sample Forms
40
FORM #1
BAYSTATE HEALTH SYSTEM
BAYSTATE MEDICAL CENTER
LASER QUALITY ASSURANCE
DEPT:
_________________________________________________________
LASER: _______________________________________________________________
DATE:
_________________________________________________________
INSPECTED BY:
___________________________________________________
MONTHLY INSPECTION
BEAM ALIGNMENT (DAILY)
INTERLOCKS
SIGNS - DOORS
SIGNS - SYSTEMS
OUTPUT (SEE POWER MEASUREMENTS)
LASER LOG (EACH CASE)
MIRROR CLEANING (AS NEEDED)
SMOKE EVACUATOR USED (AS NEEDED)
SMOKE EVACUATOR CLEANED (AS NEEDED)
EYEWEAR AVAILABLE
COVER WINDOWS (WHERE NECESSARY)
VISUAL CHECK (ELECTRICAL)
LASER POWER MEASUREMENTS
WATTS SET
WATTS MEASURED
%DIFFERENCE
Medical Physicist: ______________________________________________________________
OR
Laser Safety Officer: ____________________________________________________________
41
FORM #2
QUALITY CONTROL OF MEDICAL LASERS
DEPT. ___________________________________________________
LASER __________________________________________________
DATE ___________________________________________________
BEAM ALIGNMENT (DAILY)
INTERLOCKS
SIGNS
OUTPUT CALIBRATION (POWER/ENERGY/MEASUREMENT)
LASER LOG
MIRROR CLEANING/ALIGNMENT (AS NEEDED)
FIBER OPTICS CLEANING
SMOKE EVACUATOR CLEANING
SAFETY
DOORS
SIGNS
SYSTEMS
EYEWEAR
1. LABELED W/O.D. AND WAVELENGTH (MONTHLY)
2. INSPECTION (MONTHLY)
a. CRAZING, CRACKING, DISCOLORATION
b. CHECK FRAME
c. CHECK FOR LIGHT LEAKS
COVER WINDOWS AND RESTRICT ENTRY WHERE NECESSARY
ELECTRICAL AND H20 HAZARDS/VISUAL CHECK
LEAKS/FRAYED WIRES (DAILY)
SMOKE EVACUATOR IN USE WHEN NECESSARY
PATIENT PROTECTION
TESTING LASER SAFETY ACCESSORIES IN O.R.
42
MONTHLY
QUALITY CONTROL
AND
LASER INSPECTION
INSPECTED BY:
_________________
FORM #3
LASER LOG AND RECORD
Place pt. label here
DATE:
yes o
no o
Type of anesthesia _______________________
Microscope used:
MDA __________________________________
Microscope lens _______________ min
GRNA _________________________________
Free hand
yes o
no o
n/a o
Anesthesia Resident ______________________
Scanner:
yes o
no o
n/a o
Laser Nurse _____________________________
Fiber used:
yes o
# _____
n/a o
Circ. Nurse _____________________________
Scrub Nurse ____________________________
Laser time activated ______________________
Other Personnel _________________________
Laser time deactivated ____________________
_______________________________________
Laser mode(s) used _______________________
_______________________________________
Watts used _____________________________
Laser Type _____________________________
Total joules _____________________________
Serial # ________________________________
Total pulses _____________________________
Diagnosis ______________________________
Time sec. ______________________________
Procedure ______________________________
_______________________________________
Windows Covered
yes o
n/a o
Eye protection used on patient:
1. Saline moistened eye pads taped in place o
2. Aluminum foil over eye pads taped in place o
3. Green tinted Yag laser glasses o
4. Clear plastic CO2 laser glasses o
Laser mouth guard used on patient
yes o
no o
n/a o
Comments:________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
43
FORM #4
LASER PRIVILEGE APPLICATION FORM
Category: Physicians
1. Name: ______________________________________________________________________
2. Department: _________________________________________________________________
3. Address: ____________________________________________________________________
4. Date: _______________________________________________________________________
5. Laser Training: _______________________________________________________________
_______________________________________________________________
A. Courses:
Name: ___________________________________________________________________
Date: ____________________________________________________________________
Location: _________________________________________________________________
Hours - Didactic (8 hours minimum): __________________________________________
Hands On (4 hours minimum): _________________________________________
(Attach supplemental sheets if necessary)
Please enclose certification from laser courses
B. Residency Fellowship Laser Experience (if applicable):
Institution: ________________________________________________________________
Department: _______________________________________________________________
Department Chairman: ______________________________________________________
(Enclose letter from department chairman regarding laser proficiency. See general guidelines)
44
LASER PRIVILEGE APPLICATION FORM-PAGE 2
C. Other (e.g., Preceptorship etc. – explain)
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
6. Type of Laser:
6. _______ CO2
7. _______ Nd Yag
8. _______ Dye
9. _______ Argon
7. Prior case experience as primary laser therapist (please enclose copies of operative note reports
with patient name removed to preserve confidentiality):
Laser Wavelength or Type of Laser Procedure Complications DATE:
(e.g., CO2, Argon, Dye, Yag)
1. ________________________________________________________________________
2. ________________________________________________________________________
3. ________________________________________________________________________
4. ________________________________________________________________________
5. ________________________________________________________________________
FOR LASER COMMITTEE ONLY
8. Institution Preceptorship Cases:
Preceptor:
Laser Wavelength or Type of Laser Procedure Complications DATE:
(e.g., CO2, Argon, Dye, Yag)
1. ________________________________________________________________________
2. ________________________________________________________________________
3. ________________________________________________________________________
4. ________________________________________________________________________
5. ________________________________________________________________________
45
FORM #5
LASER OPERATOR SKILLS VALIDATION
1. Applicant has read policies and procedures.
___________
2. Certificate of attendance at an approved course of not less than ________CEUs, has been submitted.
___________
3. Passed the baseline eye exam.
___________
4. Attended equipment in service by LSO.
___________
5. Knows security procedure for obtaining keys.
___________
6. Follows safety precautions while setting up the room and assembly equipment.
___________
7. Knows how to assemble laser delivery systems, and accessory equipment.
___________
8. Can perform daily maintenance procedures.
___________
9. Operates control panel properly:
power settings
___________
time exposure
___________
standby/ready
___________
emergency off
___________
shutter
___________
10. Test fires / calibrates laser output.
___________
11. Assembles, checks, operates smoke evacuator system.
___________
12. Positions laser, footpedal, and delivery systems.
___________
13. Completes all documentation.
___________
14. Knows proper methods for cleaning and storing.
___________
15. Demonstrates ability to monitor a laser safe room.
___________
46
FORM #6A
COMMONWEALTH OF MASSACHUSETTS
DEPARTMENT OF PUBLIC HEALTH
RADIATION CONTROL PROGRAM
APPLICATION FOR REGISTRATION OF A LASER FACILITY
NOTE: Registration is required only for facilities using ANSI Class 3b or 4 lasers.
FACILITY NAME: ___________________________________________________________________
ADDRESS: _____________________________________________________________________
CITY: __________________________ STATE: ____________ ZIP CODE: __________
FACILITY TELEPHONE NUMBER: _______________________________________________
NAME OF THE CONTACT PERSON AT THE FACILITY REGARDING THE USE OF
THE LASER(S):
_________________________________________ TITLE: ___________________
TELEPHONE NUMBER: ________________________________________________________
NAME OF THE LASER SAFETY OFFICER (LSO): _______________________________________
ADDRESS OF THE LSO, IF OTHER THAN THAT OF THE FACILITY:
ADDRESS: ___________________________________________________________________
___________________________________________________________________
CITY: __________________________ STATE: ____________ ZIP CODE: __________
RSO TELEPHONE NUMBER: ___________________________________________
NATURE OF THE LASER FACILITY’S LASER USE:
o industrial processing
o optical fiber communication systems
o industrial research
o education
o entertainment (i.e., laser light show)
o health care
o manufacturer of lasers or laser containing products
Please complete and attach an INVENTORY OF ANSI CLASS 3b and 4 LASERS Form
I, ________________________________(as the facility owner or the designee for the owner)
certify that the above named facility is complying with the applicable requirements of the
American National Standards Institute Z136 Guidelines and 105 CMR 121.000.
SIGNATURE and DATE: ______________________________________________________________
47
48
Laser
Manufacturer
Laser
Model
Laser
Serial
Number
o 3b
o 4
o 3b
o 4
o 3b
o 4
o 3b
o 4
o 3b
o 4
(check one)
ANSI
Z136.1
Laser Class
Laser
Medium
Describe the Application for Which the
Laser is Being Used.
FACILITY: _____________________________________________________________DATE: ___________________________
INVENTORY OF ANSI CLASS 3b AND 4 LASERS
FORM #6B
XI. Operational Procedures
Procedure #1 - Standards for Approval of Laser Use by Health Care
Professionals
Education
V. Licensed physicians, registered nurses*, certified technologists
or allied health science professionals with Bachelors degrees in
physical sciences or engineering.
*Note: Specific credentials for human use of lasers for different categories
will be established by the Laser Safety Committee. Copies of present
requirements used at Baystate Medical Center, Inc., are enclosed.
e.g. ,
Categories:
Physicians
Nurses
Laser Technicians
Knowledge and Didactic Training
1. Fundamentals of laser radiation
2. Bioeffects of laser radiation
3. Relations of specular and diffuse relations
4. Laser standards and regulations
5. Radiation and non-radiation hazards
6. Safety policies and control procedures
7. Medical surveillance and ancillary problems
Practical Experience
8. Document at least four (4) to six (6) hours of “hands-on”
experience in use and operation of lasers
49
Operational Procedures
Policy/Category: Standards to Credential Physicians in Laser Therapy
Purpose
1. To establish a criterion for delineation of privileges for laser
therapy.
2. To assure safe use of laser therapy both for patients and health
care personnel.
Recommendations
1. All physicians utilizing the laser must be recommended by the
Laser Committee for use of specific wavelengths and type of
laser.
2. The Laser Committee shall forward its recommendations to the
appropriate department chairman concerning approval of application for laser privileges.
3. The following are general guidelines established by the Laser
Committee for the use of all lasers. In addition, the various
departments/divisions shall establish their own guidelines,
which shall have been submitted to the Laser Committee for
approval. New applicants would be required to fulfill both the
general and the more specific requirements.
General Guidelines
A. Laser training courses must be taken including at least 8
hours didactic lectures—documentation is required.
B. At least 4 hours of direct hands-on experience with lasers
either in the laboratory or in human therapy must be
documented.
50
Operational Procedures
C. The laser operator must have performed a minimum of 3
cases utilizing a specific wavelength and type of laser in an
assistant or primary role prior to the granting of specific
laser privileges. Documentation is required.
D. Physicians trained in laser therapy while in residency or
fellowship should have a letter from the department chairman stating that the applicant has met the above requirements and has a proficiency in laser therapy.
E. There shall be a preceptorship required for all physicians
applying for specific wavelength and type of laser privileges.
The exception will be recommendation #5 (see below).
F. Privileges and permission to use laser systems are subject to
laser safety and quality control procedures established by the
Radiation Safety Committee to meet regulatory compliance
requirements and national standards.
4. Physicians utilizing a particular laser for the first time in human
therapy at the institution shall have a physician from the institution previously credentialed in that particular therapy present at
the first 3 cases in a preceptorship role. This preceptor shall then
make recommendations to the Laser Committee regarding the
applicant’s proficiency with regard to laser therapy.
5. New laser technology and therapy shall not be discouraged at
the institution. In the event that no physician in the institution is
clinically experienced in the specific new technology or application, that physician will be considered for the recommendation of privilege after review by the Laser Committee providing
adequate education is documented.
51
Operational Procedures
6. Any experimental or research protocols involving the laser shall
be prospectively reviewed by the Laser Committee. Recommendations shall be forwarded to the appropriate committee or
chairman.
Note:
Other categories included are:
Nurses
Laser Technicians
Policy/Category: Standards to Credential Nurses in Laser Therapy
Credentialing of Nurses
1. All institutional nursing staff assisting physicians in laser therapy
must complete the nursing orientation program.
2. Clinical laser workshops include:
a. Four hours of didactic lectures
b. Two hours of hands-on laboratory experience
The Role of Laser Nurses
1. Laser nurses should be fully knowledgeable about the operation
handling and minor troubleshooting concerning the laser.
2. Nurses should be responsible to ensure that laser safety standards are carried out (e.g., traffic control, safety goggle usage,
ventilation, etc.).
3. Laser nurses should not be the primary circulating nurse for the
procedure, but should physically stay in close proximity to the
laser during use.
4. Laser nurses should evaluate the function and carry out pre-op
tests prior to each procedure.
52
Operational Procedures
5. The laser nurse should keep the laser in stand-by mode while
not in operation.
Policy/Category: Credentials and Orientation for Laser Technicians*
Approval
•
All institutional laser technicians must be approved by the Laser
Committee
Requirements for approval
1. Attendance at Laser Training Course offered for clinical use of
medical lasers. Course should include: Refer to Procedure #1
Eight hours didactic per wavelength, including basic laser
physics, soft tissue interaction and safety.
2. Two hours “Hands-On” laboratory experience with a laser
credentialed physician or qualified laser technician.
3. Basic knowledge of anatomy.
4. Basic knowledge of sterile technique and procedures for the
Laboratory and Operating Room.
Orientation
•
Laser technicians must be oriented to basic troubleshooting and
design features of the laser systems by laser distributors or
manufacturing companies.
*Note: Service engineers and maintenance personnel are included in this category.
53
Operational Procedures
Procedure #2 - Pre/Post-Operative Safety Checklist
1. Physician certified by hospital for wavelength laser used. Laser
nurse/technician available to operate laser controls. Laser key
obtained.
2. Doors to room closed.
3. Laser signs on doors.
4. Protective eyewear available.
5. Basin of saline available and location of fire extinguisher known.
6. Absences of flammable solutions or preps.
7. Wet sponges used to protect surrounding tissue where indicated.
Patient’s eyes protected.
8. Specially designed instrumentation available (non-reflective metals,
titanium, rhodium or quartz) where indicated.
9. When performing airway surgery, appropriate endotracheal tubes
used, if indicated, and O2 concentration maintained at 30-40%, or
lower.
10. When working around the anus, if bowel prep has not been done,
rectum packed with wet sponge.
11. Smoke evacuator used as needed.
12. Maintain Laser Safety Log.
13. When laser not in use, put in “STANDBY MODE.” If laser is to be
left unattended, it must be turned off.
14. The laser beam shall NEVER be directed at personnel.
54
Operational Procedures
Procedure #3 - Practical “Rules of Thumb” for Laser Safety
Some good procedures to follow in the use of surgical lasers are:
1. Draping the immediate area of the surgical incision with wet
towels (i.e., sterile solution) rather than dry towels to avoid
towel combustion.
2. In determining proper beam focus, exposure time, and power
level, never aim laser at a target without an absorptive backstop.
3. Be aware that there can be a difference between the power output indicated on the laser system meter and power delivered
into the tissues.
4. The use of focusing guides, which not only assist the surgeon in
keeping the focal spot on the tissue but also reduce the chance
of hazardous specular reflection. In this regard, one of the best
safety design strategies is the use of a short-focal length lens in
the beam delivery system.
5. Exclusion of combustible anesthetic gases from laser surgical
procedures.
6. Be very careful of moving or hitting the laser. It is a very sensitive system and easy to misalign optical components. To avoid
disturbing the alignment, one could have all laser surgical units
“dedicated” to a given operating room.
7. A positive action switch, either a hand trigger squeeze switch or
fool switch, to ensure rapid shut-off in case of emergency.
8. Prohibition of misuse by unauthorized personnel with a key
switch. (Such a key switch master control is required by CDRH
federal laser standard.)
55
Operational Procedures
9. Develop and distribute Standard Operating Procedures (SOP) for
use with lasers.
10. Keep records of laser type, serial number, wavelength, output
power, beam diameter, divergency, and all inspection dates in
one central permanent place.
11. The beam exit port should be located and clearly marked.
12. All connectors of fiber optics cables to laser output must be
designed to terminate laser emission when the cable is removed.
13. The use of fiber optics light guide with a high numerical aperture will produce a rapidly diverging beam and, therefore,
reduce the distance (range) wherein a hazardous exposure may
occur.
14. Quite often, surgeons have available a fire-resistant target such
as alumina or silicon-carbide firebrick to focus a hand-held laser
“scalpel.” This target assists in developing a “feel” for the
equipment and gives a visible adjustment of the beam’s focal
spot. Metallic surfaces are unacceptable for this purpose.
15. All operating room personnel and any other observers must
wear appropriate eye protection for the type of laser being used.
16. Be aware that once the beam is on, it continues to be absorbed
by matter. Whenever the laser beam is “on” it can do damage to
other tissues. The surgeon must always aim the beam at a safe
fire resistant target when not in use.
17. Highly reflective surgical instruments are not recommended.
56
Operational Procedures
18. In order to minimize the observers in the surgical room, it is
highly recommended that signs such as “Laser Surgery In
Progress” and a danger sign be affixed to the outside of the door
leading into the operating room.
57
Operational Procedures
Procedure #4 - Non-Beam Hazards
Purpose
•
To recognize and effectively deal with a variety of potential
non-beam hazards which may be present during laser
procedures.
Policy
•
Non-beam hazards are the purview of safety and industrial
hygiene personnel, who will effect the appropriate hazard
evaluation and control.
Procedure
•
Fire
1. Never use alcohol in the operative field. Fibers may be
rinsed in hydrogen peroxide or saline intraoperatively.
2. Never place a hot fiber directly on paper drapes. Wait until
tip is cool before contact is made with flammable material.
3. Use fire-retardant drapes, damp packs or pads. Fill pelvic
cavity with Ringer’s saline or other appropriate solution
during surgery.
4. Put laser system in standby mode when procedure is interrupted or terminated.
5. Avoid high levels of oxygen in the operative field.
6. Avoid laser beam exposure of the sheaths of flexible fiber
endoscopes, since many of the sheaths are flammable.
58
Operational Procedures
•
Plume Management
1. Remove laser-generated airborne contaminants from the
energy impact site to reduce the transmission of potentially
hazardous particulates.
2. Position smoke evacuator in the operating room whenever
plume is anticipated.
3. Check operation of the plume management system prior to
the beginning of the case.
4. Check the plume filter monitor, and if needed, install a clean
filter.
5. In-line filters, with minimum 0.3 µm filtration, will be
placed between wall suction and the fluid canister for:
a. Suction line not connected to evacuator.
b. Cases producing minimal plume.
c. Failure of evacuator before or during operation.
6. Distal collection port must be no more than 2 cm from
impact site, when practical.
7. All tubing, connectors, adapters, and wands will be changed
per case, and disposed of according to biohazard
procedures.
•
Electrical Shock
1. During Service or maintenance, precautions must be taken
against electrical shock, which may be fatal.
2. HCLS lasers shall be installed and operated in conformity
with the National Electrical Code.
59
Operational Procedures
Procedure #5 - Laser Safety Education Program
The Laser
•
Physics and biological effects
•
Components of the laser system, delivery devices and
instrumentation
•
Overview of clinical applications
Administrative Controls
•
Laser Committee
•
Role of the LSO
•
Development of policies/procedures
•
Documentation methods
•
Regulations, standards, and recommended professional practices
•
Certification criteria and skills validation
•
Medical Surveillance
Perioperative Safety
•
Controlled access
•
Eye protection
•
Reflection hazards
•
Flammability hazards and draping
60
Operational Procedures
•
Electrical safety
•
Management of plume
•
Management of anesthesia in airway surgery
•
Equipment testing, aligning and troubleshooting
61
XII. Bibliography
ACMP Report VI. “Radiation Control and QA of Medical Laser Systems.”
American College of Medical Physics, 11250 Roger Bacon Drive,
Reston, VA 20190-4390 (1991).
ANSI Z136.1, “Safe Use of Lasers.” American National Standards Institute,
Inc., 1430 Broadway, New York, NY 10018 (2000).
ANSI Z136.3, “Safe Use of Lasers in Health Care Facilities.” American
National Standards Institute, Inc., 1430 Broadway, New York, NY
10018 (1996).
Control of Laser Radiation, 105 CMR 121.00. Commonwealth of
Massachusetts, Boston, Massachusetts (1997).
“Guide for Control of Laser Hazards.” American Conference of Government
Industrial Hygienists, 1330 Kemper Meadow Drive, Cincinnati, OH
45240 (1981).
Laser Safety Guides and Reference Materials, Laser Institute of America,
12424 Research Parkway, Suite 125, Orlando, FL, 32826.
Laser Safety Training Programs and Videos, Rockwell Laser Industries, P.O.
Box 43010, 7754 Camargo Road, Cincinnati, OH 45443.
Medical Devices Act, Code of Federal Regulations, Title 21, Part 1040.
Washington, DC.
63